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and reporting.
AUTHORISED REPRESENTATIVE IN clinically early in its presentation. Confirmation is either via blood
THE EUROPEAN COMMUNITY tests or direct visual inspection using microscopy. Blood tests are
more commonly used, as they are easier to perform. T. pallidum
MANUFACTURER antibody tests usually become positive two to five weeks after the
initial infection. Neurosyphilis is diagnosed by finding high
en
IN VITRO DIAGNOSTIC MEDICAL later stages of the disease the IgM reactivity to many antigens
DEVICE attenuates, IgG response remains and is responsible for the
serofast effect. Antitreponemal IgM antibodies are produced about
BATCH CODE 2 weeks after exposure, followed by IgG antibodies 2 weeks after
IgM production. Early responses are against TpN47 and some of
the flagellar proteins, followed by TpN15 and TpN17.
CATALOGUE NUMBER
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SUFFICIENT FOR assay buffer, the magnetic microbeads and ABEI Label are mixed.
The total T. pallidum antibodies present in the sample bind to the
T. pallidum specific recombinant antigens and form a sandwich
KEEP AWAY FROM SUNLIGHT complex. After incubation, ABEI Label are added again. Following
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KIT COMPONENTS
Material Supplies
y
100 50
Component
tests tests
Magnetic Microbeads: coated with
T. pallidum specific recombinant 2.5 ml 2.0 ml
antigens, containing BSA, 0.09%NaN3.
This document could not be used for the purpose of legal registration.
Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.
recombinant antigen labeled with ABEI, 22.5 ml 12.5 ml Whenever room temperature changes exceed 5 °C
Tris buffer, containing BSA, 0.09%NaN3. (recommended).
All reagents are provided ready-to-use.
SPECIMEN COLLECTION AND PREPARATION
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Internal quality control is only applicable with MAGLUMI system. blood at room temperature.
For instructions for use and target value refer to Quality Control Samples can be stored for 24 hours at 2 °C ~ 8 °C, and for 90 days
Information data sheet. User needs to judge results with their own or less at -20 °C. Avoid repeated freezing and thawing. Stored
standards and knowledge. samples should be thoroughly mixed prior to use (Vortex mixer).
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Preparation of the Reagent Integral Inspect all samples for bubbles. Remove bubbles with an
Before the sealing is removed, gentle and careful horizontal applicator stick prior to analysis. Use a new applicator stick for
shaking of the Reagent Integral is essential (avoid foam each sample to prevent cross contamination.
formation!). Remove the sealing and turn the small wheel of the Serum specimens should be free of fibrin, red blood cells or
magnetic microbeads compartment to and fro, until the color of the other particulate matter.
suspension has changed into brown. Place the Integral into the Ensure that complete clot formation in serum specimens has
reagent area and let it stand there for 30 min. During this time, the taken place prior to centrifugation. Some specimens,
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magnetic microbeads are automatically agitated and completely especially those from patients receiving anticoagulant or
resuspended. thrombolytic therapy, may exhibit increased clotting time. If the
Do not interchange integral components from different specimen is centrifuged before a complete clotting, the
reagents or lots! presence of fibrin may cause erroneous results.
Opened: Stable for 4 weeks. To ensure the best kit centrifuged at 10,000 x g for 10 minutes prior to testing.
performance, it is recommended to place opened kits in the Following centrifugation, avoid the lipid layer (if present) when
refrigerator if it’s not going to be used on-board during the next pipetting the specimen into a sample cup or secondary tube.
12 hours. Specimens must be mixed thoroughly after thawing by low
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This document could not be used for the purpose of legal registration.
Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.
Package insert instructions must be carefully followed. diluted manually. After manual dilution, multiply the result by the
Reliability of assay results cannot be guaranteed if there are dilution factor.
any deviations from the instructions in this package insert. Please choose applicable diluents or ask SNIBE for advice before
manual dilution must be processed.
Safety Precautions
CAUTION: This product requires the handling of human QUALITY CONTROL
specimens. Observe quality control guidelines for medical laboratories.
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All samples, biological reagents and materials used in the Use suitable controls for in-house quality control. Controls
assay must be considered potentially able to transmit should be run at least once every 24 hours (a run cannot
infectious agents. They should therefore be disposed of in exceed 24 hours), once per reagent kit and after every
accordance with the prevailing regulations and guidelines of calibration. The control intervals should be adapted to each
the agencies holding jurisdiction over the laboratory, and the laboratory’s individual requirements. Values obtained should
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regulations of each country. Disposable materials must be fall within the defined ranges. Each laboratory should
incinerated; liquid waste must be decontaminated with sodium establish guidelines for corrective measures to be taken if
hypochlorite at a final concentration of 5% for at least half an values fall outside the range.
hour. Any materials to be reused must be autoclaved using an
overkill approach. A minimum of one hour at 121°C is usually LIMITATIONS OF THE PROCEDURE
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bloodborne pathogens. Biosafety Level 2 or other appropriate Procedural directions must be followed exactly and careful
biosafety practices should be used for materials that contain operation must be used to obtain valid results. Any modification of
or are suspected of containing infectious agents. the procedure is likely to alter the results.
This product contains Sodium Azide; this material and its Bacterial contamination of samples or repeated freeze-thaw cycles
container must be disposed of in a safe way. may affect the test results.
Safety data sheets are available on request.
2) Interfering Substances
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Prior to loading the Reagent Kit on the system for the first time, 3) HAMA
the microbeads requires mixing to re-suspend microbeads Patient samples containing human anti-mouse antibodies (HAMA)
that have settled during shipment. may give falsely elevated or decreased values. Although
HAMA-neutralizing agents are added, extremely high HAMA
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Pay attention to the residual liquids which has dried on the kit The analyzer automatically calculates the concentration of T.
surface. pallidum antibodies in each sample by means of a calibration
For detailed handling precautions during system operation, curve which is generated by a 2-point calibration master curve
refer to the SNIBE service information. procedure. The results are expressed in mIU/ml. For further
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immunoassay (CLIA) analyzer. Each test parameter is identified Results obtained with the MAGLUMI Syphilis assay can be
via a RFID tag on the Reagent Integral. For further information interpreted as follows:
please refer to the operating instructions of MAGLUMI Fully-auto Non-reactive: A result less than 1.0 mIU/ml (<1.0 mIU/ml) is
chemiluminescence immunoassay (CLIA) analyzer . considered to be negative.
Reactive: A result greater than or equal to 1.0 mIU/ml (≥1.0 mIU/ml)
is considered to be positive.
Assay results should be interpreted in conjunction with the
115 Syphilis -V3.0-en-EU 2016-07 3/4
This document could not be used for the purpose of legal registration.
Please only refer to the current product lot insert enclosed with the kits package for execution and reporting.
patient’s clinical presentation, history, and other laboratory results. times for each level to calculate the coefficient of variation.
All initially reactive should be redetermined in duplicate with the Sample#ID
Mean SD CV
(mIU/ml) (mIU/ml) (%)
MAGLUMI Syphilis. If the concentration values <1.0 mIU/ml are
Low Positive 2.512 0.131 5.21
found in both cases, the samples are considered negative for Moderately Positive 20.011 0.301 1.50
antibodies against T. pallidum. And repeatedly reactive samples High Positive 100.827 3.200 3.17
must be confirmed according to recommended confirmatory Negative Control 0.009 0.005 NA
algorithms. Positive Control 10.009 0.454 4.53
NA = not applicable
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PERFORMANCE CHARACTERISTICS
1) Specificity 4) Performance Panel
The MAGLUMI Syphilis assay was evaluated for potential The Syphilis Mixed Titer AccuSetTM Performance Panel Modified
cross-reactivity with other viral infections and disease state PSS202(M2) is intended for use by diagnostic manufacturers,
specimens. The results are shown in the table below: researchers, and clinical laboratories to develop, evaluate, or
Number of troubleshoot syphilis test methods. Characterized samples and
MAGLUMI
Clinical expected comprehensive data are provided for comparative analysis.
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Syphilis positive
Category negative Trinity
result Performance Panel Snibe Olympus
samples Biotech
TOXO IgG 10 0 Modified Syphilis PKTM
CAPTIATM
TOXO IgM 10 0 PSS202(M2) (mIU/ml)# TP Syphilis*
Syphilis IgG*
Rubella IgG 10 0 PSS202(M2)-01 NA 4.4 Reactive
Rubella IgM 5 0 PSS202(M2)-02 183.42 3.8 Reactive
CMV IgG 10 0 PSS202(M2)-03 277.38 3.3 Reactive
PSS202(M2)-04 NA NA NA
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CMV IgM 10 0
PSS202(M2)-05 176.26 2.2 Reactive
HSV-1/2 IgG 10 0
PSS202(M2)-06 446.51 4.5 Reactive
HSV-1/2 IgM 10 0 PSS202(M2)-07 418.06 3.6 Reactive
HTLV-1/2 6 0 PSS202(M2)-08 156.08 2.3 Reactive
EBV IgG 8 0 PSS202(M2)-09 74.352 3.8 Reactive
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PSS901-01 0 0.462 1.07 NEG chain reaction[J]. Journal of clinical microbiology, 1991, 29(1):
PSS901-02 5 0.760 0.475 NEG 62-69.
PSS901-03 10 0.755 0.419 NEG
2. Lynn W A, Lightman S. Syphilis and HIV: a dangerous
PSS901-04 13 1.099 0.576 NEG
PSS901-05 31 1.768 3.68 NEG
combination[J]. The Lancet infectious diseases, 2004, 4(7):
PSS901-06 45 5.253 4.07 POS 456-466.
PSS901-07 48 11.008 4.98 POS 3. Kent M E, Romanelli F. Reexamining syphilis: an update on
PSS901-08 52 31.726 4.20 POS epidemiology, clinical manifestations, and management[J].
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